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U.S. Department of Health and Human Services

Class 2 Device Recall Unity Total Knee System

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  Class 2 Device Recall Unity Total Knee System see related information
Date Initiated by Firm July 28, 2021
Create Date September 30, 2021
Recall Status1 Terminated 3 on June 12, 2024
Recall Number Z-2611-2021
Recall Event ID 88589
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
Code Information The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021.
Recalling Firm/
Manufacturer
Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact Ms. Marie-Anne Euzen
441285659866
Manufacturer Reason
for Recall
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
FDA Determined
Cause 2
Storage
Action On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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